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"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) | Clinical Trials | Clareo Health

RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

NCT05508360•Spinal Stabilization Technologies

View on ClinicalTrials.gov

Summary

This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.

Detailed Description

This study will be a prospective, open-label, multi-center study that will collect additional safety and efficacy data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using any standard anterior, standard lateral, or minimally invasive posterolateral surgical approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is skeletally mature aged 22-70.
•Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.
•Patient has adequate disc height (6mm) at the level to be treated
•Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).
•Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100)
•Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)
•Patient has signed the approved Informed Consent Form.
•All surgeries must be approved by the Medical Advisory Board (MAB)

Exclusion Criteria

•Patient has less than 6 mm of disc height.
•Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).
•Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.
•Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
•Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
•Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).
•Patient has any known active malignancy.
•Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
•Patient has active or local systemic infection.
•Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV.
+13 more criteria

Locations (10)

CIGE: Centro de Imunologia y Genetica

Medellín, Antioquia, Colombia

Fundacion Hospitalaria San Vicente de Paul

Medellín, Antioquia, Colombia

Cediul S.A.

Barranquilla, Atlántico, Colombia

Fundación Campbell

Barranquilla, Atlántico, Colombia

Sabbag Radiólogos S.A.

Barranquilla, Atlántico, Colombia

Sociedad de Cirugia de Bogota- Hospital de San Jose

Bogotá, D.C., Colombia

Clínica Imbanaco de Cali S.A.

Cali, Valle del Cauca Department, Colombia

Pacífica Salud Hospital Punta Pacífica

Panama City, Provincia de Panamá, Panama

Sanatario Americano

Asunción, Paraguay

Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova

Tashkent, Uzbekistan

Key Dates

Start Date

August 22, 2022

Primary Completion Date

August 22, 2027

Completion Date

August 22, 2030

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Degenerative Disc DiseaseChronic Low-back Pain

Interventions

PerQdisc Nucleus Replacement System

DEVICE

Contacts

Andy Murillo

CONTACT

1 (210) 632-5444 amurillo@sstspine.com

Molly Bond

CONTACT

1 (715) 577-7527 mbond@sstspine.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Inclusion Criteria

Exclusion Criteria

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